Stretta In Reflux Uncontrolled by Intake of Inhibitors of Protons Pump (IPP).- The SIRUP Trial- Multicentric, Randomized, Double Blind, Prospective Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 62
- 试验地点
- 11
- 主要终点
- Efficiency of the treatment 6 months post-procedure
研究概览
简要总结
The aim of the study is to compare the Stretta procedure and the Sham procedure efficiency 6months post-procedure in reflux uncontrolled by intake of Inhibitors of Protons Pump (IPP) patients.
详细描述
The study is over a period of 1 year. After checking eligibility, the patient will be randomised in double blind : stretta procedure /sham procedure. Control visits will take place after 4 weeks (on site), 8 weeks (by phone), 12 weeks (by phone), 18 weeks(on site) and 24 weeks(on site).During the 24 weeks visit, the therapeutic success will be evaluated.
In case of success, endoscopic control will be performed and the patient will come back on site at week 36 and 48 (end of study). In case of therapeutic failure, the stretta procedure will be proposed to the patient without breaking the blind for the 1st procedure. The procedure will be scheduled between week 24 and week 27. The patient will come back for a visit on site at weeks 31, 36 and 48 (end of visit)
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Triple (Participant, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age ≥ 18 ans
- •Severe or moderate heartburn (at least 3 heartburn times per week), persistent under treatment with IPP
排除标准
- •Recent oeso-gastro-duodenal endoscopy(< 3 months)
- •Oesophagitis > grade A
- •Endobrachyoesophagus > C0M1
- •Hiatal Hernia > 2 cm
- •Symptoms insufficiently relieved with continued intake of IPP or with intake of IPP according to needs
- •Predominant symptom of Gastrooesophageal reflux disease other than heartburn
- •Patients contra-indicated for radiofrequency technique
- •Pregnant women
研究组 & 干预措施
Stretta procedure
Patient randomized in Stretta procedure arm will be hospitalized to have endoscopy and esophagus will receive radiofrequency.
Control visits will then take place until Month 6. At this visit endoscopic control will take place.
干预措施: Stretta procedure (Other)
Sham procedure
Patient randomized in Sham procedure arm will be hospitalized to have endoscopy. Material necessary to perform Stretta procedure will be inserted (like in Stretta procedure arm) BUT esophagus will not receive radiofrequency.
Control visits will then take place until Month 6. At this visit endoscopic control will take place.
干预措施: Sham procedure (Other)
结局指标
主要结局
Efficiency of the treatment 6 months post-procedure
时间窗: 6 months
Evaluate the efficiency of the treatment 6 months post-procedure according to the patient's answers to the 2 following items : IPP treatment taken less than 7 days /week and adequate relief of symptoms. These results will be completed by the patient on a calendar during 2 weeks before the visit week 24
次要结局
- Necessity of IPP treatment(6 months)
- Effects on digestive symptoms(1 year)
- Quality of live(6 months)
- Tolerance(1 year)
- pH-impedancemetry predictive factors(At Inclusion)
- necessity of IPP treatment(1 year)
- Quality of life(1 year)
- Efficiency(1 year)